RecruitingPhase 1/2

First-in-human Study of 7MW4911 in GI Cancer

United States200 participantsStarted 2026-01-13

Plain-language summary

This is the first-in-human study of 7MW4911 in US patients, to investigate its prelimary safety and efficacy in patients with gastrointestinal cancers.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Aged 18 and above
✓. ECOG 0-1
✓. Life expectancy ≥ 3 months
✓. Advanced or metastatic gastrointestinal cancer that has progressed after standard of care.
✓. Disease progression after the most recent treatment regimen
✓. At least one measurable lesion according to RECIST v1.1
✓. Provision of archival tumor tissue or fresh biopsy.
✓. Adequte hematologic funciton, liver function and renal function.

Exclusion criteria

✕. Other concurrent malignancy in the recent 3 years except for adequately treated carcinoma in situ.
✕. Active, untreated or symptomatic CNS metastasis
✕. Effusions that require frequent drainage
✕. Patients with active autoimmune disease, except for type I diabetes, hypothyroidism and other autoimmune disease that does not require systemic treatment.
✕. Severe respiratory disease that required hospitalization in the last 28 days.
✕. Significant and uncontrolled cardiovascular disease or events in the 6 months prior to study drug administration
✕. Poorly controlled blood glucose with fasting blood glucose above 10mmol/L
✕. Recipient of allogeneic stem cell transplant or organ transplant

What they're measuring

Incidence and rates of adverse events

Timeframe: Up to approximately 2 years

MTD, RED, and RP2D

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT07216560

SponsorMabwell (Shanghai) Bioscience Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Shaona Cai

+86-021-58332260 shaona.cai@mabwell.com

View on ClinicalTrials.gov More GI Cancers trials